Volasertib + Decitabine in Patients With Acute Myeloid Leukemia (AML)

Phase 1

Terminated

• Conditions: Leukemia, Myeloid, Acute
• Interventions: Drug: decitabine iv; Drug: volasertib iv infusion

• Registration Number: NCT02003573
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

Dose Escalation (MTD Finding) Phase: To investigate the maximum tolerated dose (MTD), safety and pharmacokinetics of different volasertib administration schedules in combination with decitabine in previously untreated AML patients \>= 65 years of age who are considered ineligible for standard intensive therapy, or patients with relapsed or refractory AML regardless of prior treatment status.

MTD Extension Phase: To collect additional data on safety, efficacy and pharmacokinetics of volasertib in combination with decitabine in previously untreated patients with AML \>= 65 years of age and considered ineligible for standard intensive therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-06
• Study Start: 2014-01-29
• Primary Completion: 2015-01-06
• Study Completion: 2016-05-15
• Results First Submitted: 2017-11-06
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-27
• Last Update Submitted: 2018-08-27
• Results First Posted: 2019-01-31
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
volasertib + decitabine	decitabine iv	dose escalation and MTD (Maximum Tolerated Dose) Extension (Note: Decitabine is a Backbone Treatment and Volasertib is Investigational Medicinal Product (IMP))
volasertib + decitabine	volasertib iv infusion	dose escalation and MTD (Maximum Tolerated Dose) Extension (Note: Decitabine is a Backbone Treatment and Volasertib is Investigational Medicinal Product (IMP))

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Dose Limiting Toxicities (DLT) in Cycle 1	4 weeks	Number of subjects with Dose Limiting Toxicities (DLT) in Cycle 1 is presented
Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1	4 weeks	The primary objective of the dose-escalation part of this study was to determine the MTD of volasertib in combination with decitabine. The MTD was to be identified based on the DLT information collected during the first treatment cycle of each dosing schedule. DLT was defined as a non-haematological drug-related toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3.; The MTD corresponded to the highest dose of volasertib and decitabine at which the incidence of DLT was ≤17% (i.e. 1/6 patients) during Cycle 1.

Trial Locations

Locations (3)

Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Washington School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States